Impureza Estriol EP Impurity E (CAS 1228-72-4) | também referida como 17-Epi-Estriol ou 16α | 17α-Estriol | é um epímero de estriol que exige monitorização rigorosa no perfil de impurezas de matérias-primas e produtos acabados. Sua configuração estereoquímica influencia propriedades fisicoquímicas e pode originar-se por epimerização ou degradação sob condições ácidas ou térmicas. Estratégias analíticas para detecção e quantificação incluem HPLC com detector UV | LC-MS e RMN para confirmação estrutural. O controlo desta impureza é crítico para garantir conformidade com especificações EP | estabelecer limites aceitáveis e definir medidas de mitigação durante desenvolvimento | síntese e armazenamento.
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